PillCysteamine Hydrochloride
Brands: Cystadrops · Cystaran · Cysteamine Hydrochloride
2 active makers
soon
soon
soon
soon
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it2 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Leadiant Biosciences, Inc. | unknown | 2 | SUPPLYING |
| Recordati Rare Diseases, Inc. | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Sep 24, 2020RECALLRecall (Class III): Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured…
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. — Recalling firm: Leadiant Biosciences, Inc. — PA and Italy
- Apr 9, 2018RECALLRecall (Class III): Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amit…
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. — Recalling firm: LEADIANT BIOSCIENCES, INC — Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
- Feb 14, 2018RECALLRecall (Class III): Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Ami…
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. — Recalling firm: LEADIANT BIOSCIENCES, INC — Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enter…